MAUDE Adverse Event Report: Inogen, Inc. Inogen One G5 Portable Oxygen Concentrator

Model Number	IO-500
Medical Device Problem Codes	Failure to Charge (1085); Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's device would shut off by itself and would not turn on.It was noted that the car charger would not work as well.The patient did not have a backup during the event.As a result, the patient experienced shortness of breath until the replacement was received.The patient has no issues with the replacement device.
Additional Manufacturer Narrative
B3: date of event is estimated.The unit came in for power port damaged.The complaint was confirmed with the mother board (j14) pin burn & damaged power input.This can happen with the overcurrent due to low voltage events.The data log shows numerous battery low errors.This means the patient runs the unit on low battery and o2 invalid that caused muffler to fill with dust.

• Brand Name: Inogen One G5 Portable Oxygen Concentrator
• Common Device Name: Inogen One G5 Portable Oxygen Concentrator
• Manufacturer (Section D): Inogen, Inc.; 600 shiloh rd; plano TX 75074
• Manufacturer (Section G): Inogen, Inc.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: greg porter ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 50780232
• Report Number: 3004672275-2026-00291
• Device Sequence Number: 16141056
• Product Code: CAW
• UDI-Device Identifier: 00817131020162
• UDI-Public: (01)00817131020162
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown